Pharmacokinetic Study of Subcutaneous Testosterone Enanthate

NCT02233751 | Completed Phase 1 Results FDA Drug FDA Device

• 1 other identifier: QST-14-004
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of pharmacokinetics of subcutaneous testosterone enanthate

Conditions

Hypogonadism

Keywords

Healthy Adult Males

Outcome Measures

Primary Outcomes (3)

• Maximum Concentration (Cmax) for Serum Testosterone and Testosterone Enanthate

  Cmax = Maximum blood concentration (ng/dL) of TT=Total Testosterone and TE=Testosterone Enanthate

  Maximum serum concentrations occurring during an 8 days study window

• Area Under the Concentration-time Curve From Time Zero to Time t

  AUC(0-168h) (ng⋅hr/dL) = area under the concentration-time curve from time zero to Day 8 (1 week);

  168 hrs

• Area Under the Concentration-time Curve From Time Zero to Infinity

  AUC(0-inf) (ng⋅hr/dL) = area under the concentration-time curve from time zero to infinity

  time zero to infinity

Secondary Outcomes (4)

• Time to Maximum Concentration (Tmax)(hr)

  The sample time of Cmax during a 168 hour sampling interval

• Half-life (t 1/2)(hr)

  168 hours

• Clearance CL/F (L/hr)

  168 hours

• Vd/F (L)

  168 hours

Study Arms (2)

Testosterone enanthate auto-injector - 50 mg

EXPERIMENTAL

Testosterone enanthate auto-injector - 50 mg (SC injection)

Combination Product: Testosterone enanthate auto-injector

Testosterone enanthate auto-injector - 200 mg

EXPERIMENTAL

Testosterone enanthate auto-injector- 200 mg (SC injection)

Combination Product: Testosterone enanthate auto-injector

Interventions

Testosterone enanthate auto-injector COMBINATION_PRODUCT

Randomization then administration of combination product study medication according to group assignment

Testosterone enanthate auto-injector - 200 mg; Testosterone enanthate auto-injector - 50 mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult male subjects, 18-55 years of age, inclusive, at the time of signing the informed consent;
• Body weight ≥50 kg and body mass index within the range 19-30 kg/m2, inclusive, at screening;
• Medically healthy subjects with clinically insignificant screening and check-in results (medical history, 12-lead electrocardiogram \[ECG\], physical examination, and laboratory tests); and
• Subjects who are able to understand and are willing and able to give their signed informed consent before any trial-related procedures are performed.

You may not qualify if:

• Currently diagnosed or a history of asthma, urticarial, angioedema, anaphylaxis, atopic dermatitis, clinically significant abnormality of skin of the abdomen, cancer, diabetes, or any other clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, hematological, dermatological, venereal, neurological, psychiatric, or other major disorders;
• History of benign prostate hypertrophy (BPH), prostate cancer, or abnormal prostate specific antigen (PSA) values;
• PSA level \> 3 ng/ml at screening;
• Presence or history of gastrointestinal, hepatic or renal disease, or any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines;
• Systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 40 to 90 mmHg, and/or pulse rate outside the range of 40 to 100 beats per minute after one repeat at screening or check-in;
• Abnormal ECG at screening as judged by the Investigator;
• History of clinically significant drug and/or food allergies as determined by the Investigator;
• Allergy to sesame, sesame oil, or a history of hypersensitivity or idiosyncratic reaction to compounds related to the study drug
• Subjects undergoing current treatment with other androgens (i.e. dehydroepiandrosterone \[DHEA\]), anabolic steroids, other sex hormones, or drugs that interfere with the metabolism of testosterone (i.e. opioids, anastrozole, clomiphene, dutasteride, finasteride, flutamide, ketoconazole, spironolactone, and testolactone);
• Subjects treated within the past 12 months with estrogens, gonadotropin releasing hormone (GnRH) agonists, or growth hormone;
• Prescription, over the counter medications, vitamins, herbal and dietary supplements taken within 7 days or 5 half-lives (whichever is longer) prior to the dose of study medication and duration of the study;
• Positive screen for human immunodeficiency virus (HIV), hepatitis B, and/or hepatitis C at screening;
• Positive urine screen for drugs of abuse (amphetamine, barbiturates, benzodiazepines, cocaine, marijuana, methadone, methamphetamines, oxycodone, and opiates) or positive breath alcohol test at screening and check-in

Sponsors & Collaborators

• Antares Pharma Inc.: lead

Study Sites (1)

Medpace Clinical Pharmacology Unit

Cincinnati, Ohio, 45227, United States

Location

MeSH Terms

Conditions

Hypogonadism

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Results Point of Contact

• Title: Jonathan Jaffe, MD
• Organization: Antares Pharma, Inc.

jjaffe@antarespharma.com

609-359-3020

Study Officials

• Jonathan Jaffe, MD

  Antares Pharma Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The dose assignment was random among the enrolled participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2014
• First Posted: September 8, 2014
• Study Start: September 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: April 19, 2019
• Results First Posted: April 19, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)